What are the responsibilities and job description for the Global Head of Clinical Affairs & Trials position at Hoya Vision Care?
Essential Duties and Responsibilities Include the following. Other duties may be assigned:
- Designs and delivers strategic translation of business objectives into clinical requirements for clinical trials, investigator-sponsored studies, publications, and meeting regulatory requirements for clinical evaluations and post-market surveillance.
- Manages and develops an internal or external global team of Clinical Project Managers and Clinical Trial Coordinators.
- Operates as a recognized expert, responsible for design of clinical trials, including protocol development, clinical trial discussions with regulatory authorities, and development of timeline and budget.
- Manages the process of screening, qualifying, selecting, and contracting with investigators, sites, and vendors required for the conduct of clinical trials.
- Obtains necessary clinical trial approvals from IRBs/EC's and regulatory bodies such as the FDA, Health Canada, and Competent Authorities.
- Ensures studies are on track for site initiation, patient recruitment, and enrollment, and take corrective actions where necessary to address issues.
- Ensures clinical results are interpreted and documented clearly and concisely for regulatory submissions and publications.
- Maintains surveillance of published literature and clinical results for Hoya and competitive products across all pertinent indications for strategic purposes and use in regulatory submissions.
- Develops, maintains and expands collaborations with outside clinical investigators, researchers and thought leaders to facilitate the optimum performance of clinical development programs.
- Develops SOPs and work instructions to assure internal files and clinical study files (patient; site; country) conform to Good Clinical Practice regulations and standards.
- Ensures adherence to protocols and compliance with regulatory (FDA/ICH/GCP) guidelines as well as SOP procedures.
- Identifies clinical training needs and develop training materials for in-house and clinical site use.
- Provides oversight of investigator-sponsored studies.
- Develops budgets for all clinical projects and adheres to company financial goals.
Behavioral Competencies:
Strategic Mindset
Sees ahead to future possibilities and translates them into breakthrough strategies. Strong big-picture thinker; makes frequent, clear references to the organization's vision and strategy and the efforts required to drive them forward. Effectively integrates long-term opportunities and challenges with day-to-day activities.
Ensures Accountability
Holds self and others accountable to meet commitments. Creates team collaboration to hold each other accountable for goals, adherence to policies and procedures. Tracks team metrics and milestones, redirecting effort, as necessary, for continued progress.
Manages Complexity
Makes sense of complex, high quantity, and sometimes contradictory information to effectively solve problems. Identifies the systematic elements of issues' major connections, linkages, and interdependencies. Ensures the
organization has reliable ways to gather needed information.
Optimizes Work Processes
Knows the most effective and efficient processes to get things done, with a focus on continuous improvement. Motivates people to produce highest-quality outcomes and pursue continuous improvement. Ensures problems are
well examined and improvements are integrated into all relevant work processes.
Balances Stakeholders
Anticipates and balances the needs of multiple stakeholders. Shares stakeholder feedback while inspiring others to consistently seek input and learn from their internal and external stakeholders. Promotes an environment of high ethical standards and cross-cultural sensitivity in working with all stakeholders.
Business Insight
Applies knowledge of business and the marketplace to advance the organization's goals. Ensures the team understands and discusses relevant industry changes. Provides strong messages about how people's efforts make a difference to the broader organization.
Plans and Aligns
Plans and prioritizes work to meet commitments aligned with organizational goals. Creates nimble plans accounting for a range of risks and contingencies. Achieves greater cohesion, integration, and alignment between own group and other areas. Both persistent in adversity and nimble in change.
Financial Acumen
Interprets and applies key financial indicators to make better business decisions. Identifies and leverages the best financial and quantitative indicators to gain an in-depth understanding of organizational performance. Creates an
environment and tools for people to take ownership of financial decisions.
Instills Trust
Gains the confidence and trust of others through honesty, integrity, and authenticity. Models honesty and authenticity and encourages others to be up front with one another. Demonstrates reliability and places a
strong emphasis on the team meeting its commitments. Fairly represents others' positions.
Collaborates
Builds partnerships and works collaboratively with others to meet shared objectives. Enhances and improves collaboration among coworkers and with external partners. Solicits ideas from diverse colleagues, gives credit well and generously.
Communicates Effectively
Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences.
Drives Vision and Purpose
Paints a compelling picture of the vision and strategy that motivates others to action. Strong champion for the organization's vision; energizes people to commit to this long-term direction. Regularly and
enthusiastically describes how people's efforts make a difference.
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and/or Experience:
- Advanced Degree in ophthalmology, optometry, or vision science.
- Experience selecting and managing external clinical support resources.
- 10 years progressive leadership
- Minimum of 15 years of experience in progressive research and product development leadership roles within global companies that develop, manufacture, and sell ophthalmic medical devices
- Experience in setting and scaling the research and development function, with the proven ability to attract, inspire, motivate, and retain top-tier talent.
- Proven ability to establish, articulate, and implement a concrete product development strategy that clearly aligns with corporate and commercial goals.
Travel for this role is estimated at 50%.
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this Job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this Job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.
Not Exclusive:
The duties outlined in this document are not limited to what Is presented and are not exclusive.
You may be asked from time to time to perform additional duties by your supervisor or another member of management.
- Designs and delivers strategic translation of business objectives into clinical requirements for clinical trials, investigator-sponsored studies, publications, and meeting regulatory requirements for clinical evaluations and post-market surveillance.
- Manages and develops an internal or external global team of Clinical Project Managers and Clinical Trial Coordinators.
- Operates as a recognized expert, responsible for design of clinical trials, including protocol development, clinical trial discussions with regulatory authorities, and development of timeline and budget.
- Manages the process of screening, qualifying, selecting, and contracting with investigators, sites, and vendors required for the conduct of clinical trials.
- Obtains necessary clinical trial approvals from IRBs/EC's and regulatory bodies such as the FDA, Health Canada, and Competent Authorities.
- Ensures studies are on track for site initiation, patient recruitment, and enrollment, and take corrective actions where necessary to address issues.
- Ensures clinical results are interpreted and documented clearly and concisely for regulatory submissions and publications.
- Maintains surveillance of published literature and clinical results for Hoya and competitive products across all pertinent indications for strategic purposes and use in regulatory submissions.
- Develops, maintains and expands collaborations with outside clinical investigators, researchers and thought leaders to facilitate the optimum performance of clinical development programs.
- Develops SOPs and work instructions to assure internal files and clinical study files (patient; site; country) conform to Good Clinical Practice regulations and standards.
- Ensures adherence to protocols and compliance with regulatory (FDA/ICH/GCP) guidelines as well as SOP procedures.
- Identifies clinical training needs and develop training materials for in-house and clinical site use.
- Provides oversight of investigator-sponsored studies.
- Develops budgets for all clinical projects and adheres to company financial goals.
Behavioral Competencies:
Strategic Mindset
Sees ahead to future possibilities and translates them into breakthrough strategies. Strong big-picture thinker; makes frequent, clear references to the organization's vision and strategy and the efforts required to drive them forward. Effectively integrates long-term opportunities and challenges with day-to-day activities.
Ensures Accountability
Holds self and others accountable to meet commitments. Creates team collaboration to hold each other accountable for goals, adherence to policies and procedures. Tracks team metrics and milestones, redirecting effort, as necessary, for continued progress.
Manages Complexity
Makes sense of complex, high quantity, and sometimes contradictory information to effectively solve problems. Identifies the systematic elements of issues' major connections, linkages, and interdependencies. Ensures the
organization has reliable ways to gather needed information.
Optimizes Work Processes
Knows the most effective and efficient processes to get things done, with a focus on continuous improvement. Motivates people to produce highest-quality outcomes and pursue continuous improvement. Ensures problems are
well examined and improvements are integrated into all relevant work processes.
Balances Stakeholders
Anticipates and balances the needs of multiple stakeholders. Shares stakeholder feedback while inspiring others to consistently seek input and learn from their internal and external stakeholders. Promotes an environment of high ethical standards and cross-cultural sensitivity in working with all stakeholders.
Business Insight
Applies knowledge of business and the marketplace to advance the organization's goals. Ensures the team understands and discusses relevant industry changes. Provides strong messages about how people's efforts make a difference to the broader organization.
Plans and Aligns
Plans and prioritizes work to meet commitments aligned with organizational goals. Creates nimble plans accounting for a range of risks and contingencies. Achieves greater cohesion, integration, and alignment between own group and other areas. Both persistent in adversity and nimble in change.
Financial Acumen
Interprets and applies key financial indicators to make better business decisions. Identifies and leverages the best financial and quantitative indicators to gain an in-depth understanding of organizational performance. Creates an
environment and tools for people to take ownership of financial decisions.
Instills Trust
Gains the confidence and trust of others through honesty, integrity, and authenticity. Models honesty and authenticity and encourages others to be up front with one another. Demonstrates reliability and places a
strong emphasis on the team meeting its commitments. Fairly represents others' positions.
Collaborates
Builds partnerships and works collaboratively with others to meet shared objectives. Enhances and improves collaboration among coworkers and with external partners. Solicits ideas from diverse colleagues, gives credit well and generously.
Communicates Effectively
Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences.
Drives Vision and Purpose
Paints a compelling picture of the vision and strategy that motivates others to action. Strong champion for the organization's vision; energizes people to commit to this long-term direction. Regularly and
enthusiastically describes how people's efforts make a difference.
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and/or Experience:
- Advanced Degree in ophthalmology, optometry, or vision science.
- Experience selecting and managing external clinical support resources.
- 10 years progressive leadership
- Minimum of 15 years of experience in progressive research and product development leadership roles within global companies that develop, manufacture, and sell ophthalmic medical devices
- Experience in setting and scaling the research and development function, with the proven ability to attract, inspire, motivate, and retain top-tier talent.
- Proven ability to establish, articulate, and implement a concrete product development strategy that clearly aligns with corporate and commercial goals.
Travel for this role is estimated at 50%.
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this Job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this Job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.
Not Exclusive:
The duties outlined in this document are not limited to what Is presented and are not exclusive.
You may be asked from time to time to perform additional duties by your supervisor or another member of management.
